Senior Pharmaceutical Toxicologist & Project Lead

BlueRidge Life Sciences; Florida; On-site; USD 180,000 - 240,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, including consulting or industry. The role focuses on nonclinical safety program oversight, data interpretation, and regulatory submissions.

The candidate will collaborate with cross-functional teams, provide regulatory strategy, and interact with agencies to advance drug development programs. A Ph.D.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT desired but not required.
• 15+ years of pharmaceutical consulting and/or industry and/or government experience.
• Strong understanding of ICH/guidance for nonclinical drug development.
• Experience overseeing nonclinical safety programs through all development phases.
• Experience writing regulatory sections and interacting with agencies.

Responsibilities

• Oversee nonclinical safety programs and study design; interpret TK/PK data.
• Lead toxicology project teams; serve as toxicology representative.
• Prepare and review regulatory submission sections (pre-IND, IND/CTA, NDA/BLA).
• Engage with regulatory authorities (FDA, EMA, MHRA).
• Travel up to ~20% may be required.

Skills

Toxicology expert

Drug development

Regulatory guidance (ICH)

Nonclinical safety

Project management

Scientific writing

Regulatory liaison

Team leadership

Education

Ph.D. in toxicology

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist with 15+ years in biopharmaceutical/pharmaceutical settings, including consulting or industry. The role focuses on nonclinical safety program oversight, data interpretation, and regulatory submissions.

The candidate will collaborate with cross-functional teams, provide regulatory strategy, and interact with agencies to advance drug development programs. A Ph.D.